Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

NCT04376567 | Terminated Results

• 1 other identifier: 0702
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.

Conditions

End Stage Renal Failure; Hemodialysis Access Failure; Arterio-venous Fistula

Keywords

Renal failure; Upper extremity arteriovenous fistula; Brachial basilic arteriovenous fistula

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis

  Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.

  6 months

Secondary Outcomes (3)

• Number of Participants Who Had Catheter Related Complications

  6 months

• Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation

  6 months

• Patient-Reported Outcomes Measurement Information System Scores Over 6 Months

  6-month

Study Arms (2)

One stage approach

ACTIVE COMPARATOR

To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure.

Procedure: One stage approach

Two Stage approach

ACTIVE COMPARATOR

To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured.

Procedure: One stage approach

Interventions

One stage approach PROCEDURE

Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.

Also known as: Two stage approach

One stage approach; Two Stage approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• ESRD receiving hemodialysis in need for new hemodialysis access;
• Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
• Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
• Life expectancy ≥ 12 months;

You may not qualify if:

• Life expectancy \< 12 months;
• Brachial artery stenosis or occlusion;
• A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
• Current immunosuppressive medication, chemotherapy or radiation therapy;
• Pregnancy or lactation

Sponsors & Collaborators

• Tze-Woei Tan: lead
• University of Utah: collaborator
• Rancho Los Amigos National Rehabilitation Center: collaborator

Study Sites (1)

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Limitations and Caveats

Study was terminated early due to low enrollment and PI leaving the institution.

Results Point of Contact

• Title: Tze-Woei Tan
• Organization: University of Arizona

tze-woei.tan@med.usc.edu; ttan@arizona.edu

3234426835

Study Officials

• Tze-Woei Tan, MD

  Banner University Medical Center Tucson/University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor of Surgery

Model Details: Assigned to either a one-stage or two-stage approach for brachial-basilic arteriovenous fistula (BBAVF) creation in a 1:1 ratio.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: May 6, 2020
• Study Start: October 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)